a double-blind single-ascending dose (sad) and multiple-ascending dose (mad) study to investigate the safety, tolerability, and pharmacokinetics of ro7049389 in healthy chinese participants

Conditions: Hepatitis B Virus

Summary: this study will assess the safety and tolerability of ro7049389 compared to placebo in single- and multiple-ascending doses in healthy chinese participants.


Eligibility criteria:
inclusion criteria * chinese healthy male and female subjects, 18 to 60 years of age, inclusive. * a body mass index (bmi) of between 19 to 27 kg/m2 inclusive, and a body weight of at least 45 kg. * women should be of non-childbearing potential. female subjects must be either surgically sterile (by means of hysterectomy and/or bilateral oophorectomy) or post-menopausal for at least one year (defined as amenorrhea \>/=12 consecutive months without another cause, and confirmed by follicle stimulating hormone level \>35 miu/ml). * for men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm exclusion criteria * pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are pregnant or lactating. * history or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis. * personal history of congenital long qt syndrome or family history of sudden death. * history of gilbert's syndrome. * history of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral or inhaled corticosteroids) \</=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study. * subjects who have had significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration. * any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable). * electrocardiogram (ecg) with qrs and/or t-wave judged to be unfavorable for a consistently accurate qt measurement (e.g., neuromuscular artifact that cannot be readily eliminated, arrhythmias, indistinct qts onset, low amplitude t-wave, merged t- and u waves, prominent u-waves) * creatinine clearance (crcl) \</=70 ml/min (using the cockcroft-gault formula) * positive test at screening of any of the following: hepatitis a (hav igm ab), hepatitis b (hbsag), hepatitis c (hcv rna or hcv ab) or human immunodeficiency virus 1 and 2 (hiv ab). * participation in an investigational drug or device study within 90 days prior to screening or more than 4 times per year. * donation or loss of blood over 500 ml within 3 months prior to screening. * any suspicion or history of drug and/or alcohol abuse within the last year. * history (within 3 months of screening) of alcohol consumption exceeding two standard drinks per day on average (1 standard drink = 10 grams of alcohol). alcohol consumption will be prohibited at least 48 hours before screening, 48 hours before and 48 hours after each dose, and 48 hours before each scheduled visit. * use of \>5 cigarettes or equivalent nicotine-containing product per day. * taking any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 2 weeks of first dosing or within 5 times the elimination half-life of the medication prior to first dosing (whichever is longer). occasional acetaminophen/paracetamol is allowed. * subjects under judicial supervision, guardianship or curatorship.